TUCoPS :: Cyber Law :: siezerlx.txt

Feds sieze relaxation machines!

FDA says Seattle company's devices not scientifically tested
By David Shaeffer,  Seattle Times staff reporter
   Federal agents have seized the inventory of a Seattle company that
manufactures relaxation machines.
   Agents of the U.S.  marshal's office and the Food and Drug Adminis-
tration yesterday seized products made by Synetic Systems, 3822 Stone
Way N. [Seattle]
   Daryl Thompson, a compliance officer with the FDA, said the relax-
ation devices were seized because their sale violates the federal Food,
Drug and Cosmetic Act.  He said it is against the law to market devices
"that affect the structure of function of man" unless they have been
scientifically tested to show they are safe and effective.
   Synetic Systems has not submitted its machines for testing, Thompson
   But Michael Cosgrove, production manager for the Seattle company,
said the FDA is trying to classify the company's products as medical de-
vices.  He said that the federal agency is trying to get control over
the industry but that Synetic Systems has not made medical claims.
   Among their products is a machine marketed as the Sharper Image Re-
laxation System, which includes a control box, headphones, glasses,
tapes, and a manual.
   The system flashes light and sounds, and, said Cosgrove, "We have
been told it is as good as aspirin for a non-migraine headache, although
we don't say that in our advertising."
   Thompson said the device is similar to one used by neurologists to
affect brain waves.
   He said that in order to market the device legally, Synetic Systems
would have to submit to a scientific testing process.
  Cosgrove said getting FDA approval would make the relaxation system
too expensive to produce.
   Cosgrove complained that while Synetic Systems was being shut down,
competitors were being allowed to remain in business.
   Thompson said he could not comment on other actions by the FDA but
added, "We're looking at these kinds of devices here and in other parts
of the country."

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